Early Data Presented From Real-World Registry of Medtronic’s Abre Venous Stent System

October 13, 2026—Early 30-day results from a prospective, real-world registry of the Abre venous self-expanding stent system (Medtronic) showed no stent fractures, a 0.7% rate of target lesion revascularization (TLR), and decreased pain among 151 patients treated for venous outflow obstruction.

The findings from an analysis of the Product Surveillance Registry (PSR) were presented by Paul Gagne, MD, at The VEINS 2026 conference held by the VIVA Foundation.

According to the study summary issued by The VIVA Foundation, the PSR is a prospective, global postmarket surveillance platform evaluating the safety and performance of the Abre stent in routine clinical practice. The Abre device is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.

As summarized by VIVA, 151 patients (72.8% female; mean age, 50.6 ± 17.4% years) underwent treatment with at least one Abre stent at 15 sites in Europe and the United States between June 2024 and September 2025. All patients completed 30-day follow-up.

The PSR investigators reported that there were no stent fractures and one TLR (0.7%) through 30 days. Patients also experienced a statistically significant decrease in pain by 30 days.

The summary stated that higher baseline pain was associated with greater immediate postprocedural pain. Patients treated with larger stent diameters (18–20 mm) reported greater increases in immediate pain, which subsequently decreased to levels consistent with the overall cohort by day 30.

The PSR’s primary safety endpoint is freedom from stent fracture, and its primary efficacy endpoint is TLR, both assessed through 60 months. Secondary objectives include postprocedural pain, stent patency, and patient-reported health outcomes.

Continued follow-up will provide longer-term data on device durability, reintervention, and clinical outcomes beyond the initial 30-day assessment, advised the VIVA summary.